Medicinal Products consultancy
Regulatory Affairs consultancy is a service aimed at supporting companies in the marketing and continued placing on the market of drug products. Medifocs also caters to companies looking to operate in the field of parallel imports through adequate and targeted services based on our specific knowledge and skills, which we have built up over the years.
The correct management of medicines cannot be separated from the implementation by companies of appropriate and proper quality management systems. Therefore, at Medifocs we also provide Quality Assurance activities that integrate with and supplement the regulatory affairs activities creating a unique whole.
Regulatory Affairs
- Formatting of documental CTDs into eCTDs
- Regulatory activities for parallel imports
- Technical design of packaging (with support of specialized companies)
- Graphic creation of printed materials
- Management of IPZS pharmaceutical stamps
- Management of Import/Export permits for narcotic substances and products
- Representative for dealings with the national authorities (AIFA, Ministry of Health, ISS, Embassies)
Quality Assurance
- Research, development and management of technology transfers
- Risk assessment following major changes in the manufacturing process and support during regulatory inspections
- Development of serialisation projects and possible site implementation
- Development of anti-counterfeiting projects
- Management of quality control, quality assurance and compliance status in the production of APIs, biosimilars and biologicals, sterile and non-sterile medicinal products
- Preparation for inspections and audits by regulatory bodies (FDA, AIFA, etc.)
- Support to companies in carrying out annual audit plans for suppliers in Italy and the EU
